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Spots Global Cancer Trial Database for Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

The following info and data is provided "as is" to help patients around the globe.
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Trial Identification

Brief Title: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

Official Title: A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN 144/LN-145/LN-145-S1) in Patients With Solid Tumors

Study ID: NCT03645928

Study Description

Brief Summary: A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with checkpoint inhibitors or TIL LN-144 (Lifileucel)/LN-145/LN-145-S1 as a single agent therapy.

Detailed Description: LN-144 (Lifileucel)/LN-145/LN-145-S1 is an adoptive cell transfer therapy that utilizes an autologous TIL for the treatment of patients with unresectable or metastatic melanoma, advanced, recurrent, or metastatic squamous cell carcinoma of the head and neck, and locally advanced or metastatic non-small cell lung cancer. The adoptive cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphodepletion regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2. Patients in Cohorts 1A, 2A, 3A and 3C will receive TIL plus checkpoint inhibitors. Patients in Cohorts 1B, 1C, and 3B will receive autologous TIL as a single therapy.

Eligibility

Minimum Age: 12 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of California, San Diego, La Jolla, California, United States

University of Southern California, Los Angeles, California, United States

University of California, Los Angeles, Los Angeles, California, United States

University of Colorado, Denver, Colorado, United States

Yale University, New Haven, Connecticut, United States

Georgetown University Medical Center, Washington, District of Columbia, United States

Mount Sinai Medical Center, Miami Beach, Florida, United States

Orlando Health Cancer Institute, Orlando, Florida, United States

Moffitt Cancer Center, Tampa, Florida, United States

University of Louisville, Louisville, Kentucky, United States

University of Maryland, Baltimore, Maryland, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Karmanos Cancer Institute, Detroit, Michigan, United States

Henry Ford Health System, Detroit, Michigan, United States

MD Anderson at Cooper, Camden, New Jersey, United States

Morristown Medical Center, Morristown, New Jersey, United States

Columbia University, New York, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

University of Cincinnati, Cincinnati, Ohio, United States

Ohio State University, Columbus, Ohio, United States

Avera Cancer Institute, Sioux Falls, South Dakota, United States

Huntsman Cancer Hospital, Salt Lake City, Utah, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Centre Léon Berard, Lyon, , France

Klinikum rechts der Isar der Technischen Universität München, München, Bavaria, Germany

Universitätsklinikum Carl Gustav Carus, Dresden, Sachsen, Germany

Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Lübeck, Schleswig-Holstein, Germany

Laiko General Hospital of Athens, Athens, Attiki, Greece

Attikon University General Hospital, Athens, Attiki, Greece

Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain

University Hospital Vall d'Hebron, Barcelona, , Spain

ICO l'Hospitalet - Hospital Duran i Reynals, Barcelona, , Spain

Hospital General Universitario Gregorio Marañón, Madrid, , Spain

Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain

Hospital Universitario 12 de Octubre, Madrid, , Spain

Hospital Universitario HM Sanchinarro, Madrid, , Spain

Hospital Regional Universitario de Malaga - Hospital General, Málaga, , Spain

Universitätsspital Basel, Basel, , Switzerland

Universitaetsspital Bern, Bern, , Switzerland

Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland

Guy's Hospital, London, England, United Kingdom

The Royal Marsden NHS Foundation Trust, London, England, United Kingdom

Bristol Haematology and Oncology Centre, Bristol, , United Kingdom

Contact Details

Name: Iovance Biotherapeutics Medical Monitor

Affiliation: Iovance Biotherapeutics

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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